The following data is part of a premarket notification filed by Ameda Medizintechnik Ag with the FDA for Expresse And Premier Powered Breast Pumps.
| Device ID | K973501 |
| 510k Number | K973501 |
| Device Name: | EXPRESSE AND PREMIER POWERED BREAST PUMPS |
| Classification | Pump, Breast, Powered |
| Applicant | AMEDA MEDIZINTECHNIK AG 2000 HOLLISTER DR. Libertyville, IL 60048 |
| Contact | Joseph S Tokarz |
| Correspondent | Joseph S Tokarz AMEDA MEDIZINTECHNIK AG 2000 HOLLISTER DR. Libertyville, IL 60048 |
| Product Code | HGX |
| CFR Regulation Number | 884.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-16 |
| Decision Date | 1997-12-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810725021477 | K973501 | 000 |
| 20810725020030 | K973501 | 000 |
| 10810725020040 | K973501 | 000 |
| 20810725020061 | K973501 | 000 |
| 20810725020078 | K973501 | 000 |
| 20810725020085 | K973501 | 000 |
| 10810725020750 | K973501 | 000 |
| 00810725021484 | K973501 | 000 |
| 10810725021665 | K973501 | 000 |
| 10810725020668 | K973501 | 000 |